The Recall Desk
ModerateFDA (Devices)·Z-0074-2014·Announced 2013-11-06

Zimmer Recalls NexGen Femoral Components Due to Packaging Adhesion

Zimmer, Inc. is recalling NexGen Femoral Components because the packaging bags adhere to the device surfaces. The recall covers 11,694 units distributed worldwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text describes a packaging adhesion issue without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a potential defect without confirmed harm.

Plain-English summary

Zimmer, Inc. is recalling the NexGen Femoral Component (CR-FLEX GSF POR FEM) due to a packaging defect. The low density polyethylene (LDPE) bags used to package the implants adhere to the highly polished surface of the devices.

The recall involves 11,694 units with part numbers ranging from 5752 to 5762. These devices are distributed worldwide, including in the United States and numerous international markets such as Argentina, Australia, Brazil, Canada, China, Germany, India, Japan, and Mexico.

The source text does not specify any reported injuries, illnesses, or deaths associated with this recall. The issue is identified as a physical adhesion between the packaging material and the device surface.

The recalled product

Product
NexGen¿ Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF POR FEM, C-L MINUS; CR-FLEX GSF POR FEM, C-R MINUS; CR-FLEX GSF POR FEM, D-L; CR-FLEX GSF POR FEM, D-R CR-FLEX GSF POR FEM, D-L MINUS; CR-FLEX GSF POR FEM, D-R MINUS CR-FLEX GSF POR FEM
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
11,694

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part Number Range: 5752 and 5762.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

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